Atlas FDA

SHILEY SPECIALIZED TRACHEOSTOMY TUBE

FDA 510(k) clearance K903435 · decided 1990-10-02

Clearance details

K-number
K903435
Device name
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
Applicant
Shiley, Inc.
Decision
Substantially Equivalent
Date received
1990-07-31
Decision date
1990-10-02
Days to decision
63 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Shiley

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (K251313)Covidien, LLC2025-12-29
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula (K210833)Smiths Medical Asd, Inc.2021-11-26
TRACOE vario (K203362)Tracoe Medical GmbH2021-08-05
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (K193077)Covidien2020-06-01
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133)Cook Incorporated2019-12-12
Shiley Neonatal/Pediatric Tracheostomy Tube (K182861)Covidien2019-03-22
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912)Smiths Medical Asd, Inc.2018-05-08
Weinmann Tracheostomy Exchange Set (K180034)Cook Incorporated2018-05-07
TRACOE silcosoft Tracheostomy Tube (K172720)Tracoe Medical GmbH2018-04-27
Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720)Smiths Medical Asd, Inc.2017-12-07
ProTrach Dualcare (K151404)Atos Medical AB2016-02-12
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (K150844)Covidien2015-07-14

Recalls involving this device

RecordFirmDate
Shiley Specialized Tracheostomy Tube, MSCT, Sterile EO, Made in Mexico, Tyco Healthcare Gr recall (Z-1500-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M5SCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1501-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M5.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare recall (Z-1502-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M6SCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1503-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M6.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare recall (Z-1504-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1505-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M7.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare recall (Z-1506-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1507-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M9SCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1508-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in Mexico, Tyco Healthcare recall (Z-1509-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, MFEN, Sterile EO, Made in Mexico, Tyco Healthcare Gr recall (Z-1515-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M6FEN, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1516-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1517-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in Mexico, Tyco Healthcare Gr recall (Z-1518-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1519-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1520-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico, Tyco Healthcare Gr recall (Z-1521-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1522-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in Mexico, Tyco Healthcare G recall (Z-1523-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06

PMA approvals by this applicant

RecordFirmDate
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S014)Shiley, Inc.1985-04-09
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
BJORK-SHILEY CARDIAC VALVE (P780008/S007)Shiley, Inc.1983-05-20
BJORK-SHILEY CARDIAC VALVE (P780008/S005)Shiley, Inc.1982-02-05